Laser-excimer Versus High-pressure Dilation to Treat Under-expansion of the Stent (LASER EXPAND Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Variation of the minimum luminal area (MLA)
研究概览
简要总结
The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.
详细描述
The laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification.
The investigators propose a study that serves as proof of concept for this technology (laser Excimer) used according to its intended use in this specific substrate of coronary lesions. (stent under-expansion without severe underlying calcification).The laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with:
- •Age ≥ 18 years.
- •Consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area <4 mm2 or <6 mm2 in the left main coronary artery measured by IVUs (Intravascular Ultrasound) / OCT(Optical Coherence Tomography)) and that it is not possible to dilate with a NC balloon to a maximum of 20 atm.
排除标准
- •Refusal of the patient to participate in the study.
- •Patients with life expectancy <1 year.
- •Patients with advanced kidney disease (grade IV) or liver failure (Child C)
研究组 & 干预措施
Stent under-expansion with NC Balloon
干预措施: NC ( Non- Compliant) Balloon dilatation (Procedure)
Stent under-expansion with Laser Excimer + NC Balloon
干预措施: Laser Excimer + NC Balloon (Procedure)
结局指标
主要结局
Variation of the minimum luminal area (MLA)
时间窗: During procedure
Detection of rate for Variation of the minimum luminal area (MLA) of the under-expanded stent defined as: ((MLAfinal-MLAinicial) / MLAinicial) x 100.
次要结局
- Complications during procedure(During procedure)
- Tachycardia(During procedure)
- Hyperacute thrombosis (THA)(During procedure)
- Contrast Volume(During procedure)
- Periprocedural Infarction complications(During procedure)
- No- Reflow/Slow Flow (SFL)(During procedure)
- Bradycardia(During procedure)
- Procedure time(During procedure)